The Effect of Arista on Post-Operative Bleeding and Wound Drainage Following Mastectomy
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|ClinicalTrials.gov Identifier: NCT03647930|
Recruitment Status : Completed
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Seroma||Device: Microporous Polysaccharide Hemospheres (MPH)||Not Applicable|
Seroma formation is the most common complication after mastectomy and places patients at risk of associated morbidities. Microporous Polysaccharide Hemospheres (MPH) consists of hydrophilic, plant based, polysaccharide particles and is currently used as an absorbable hemostatic agent. An animal model evaluating MPH and seroma formation after mastectomy with axillary lymph node dissection showed a significant decrease in seroma volume. Study aim was to evaluate topical MPH on the risk of post-mastectomy seroma formation as measured by total drain output and total drain days.
Prospective randomized single-blinded clinical trial of patients undergoing mastectomy for the treatment of breast cancer. MPH was applied to the surgical site in the study group and no application in the control group.
Fifty patients were enrolled; eight were excluded due to missing data. Forty-two patients were evaluated, control (n=21) vs. MPH (n=21). No difference was identified between the two groups regarding demographics, tumor stage, total drain days, total drain output, number of clinic visits, or complication rates. On a subset analysis, body mass index (BMI) greater than 30 was identified as an independent risk factor for high drain output. Post hoc analyses of MPH controlling for BMI also revealed no statistical difference.
Unlike the data presented in an animal model, no difference was demonstrated in the duration and quantity of serosanguinous drainage related to the use of MPH in patients undergoing mastectomy for the treatment of breast cancer. BMI greater than 30 was identified as an independent risk factor for high drain output and this risk was not affected by MPH use.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective randomized trial|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Arista on Post-Operative Bleeding and Wound Drainage Following Mastectomy: A Prospective Randomized Trial|
|Actual Study Start Date :||May 15, 2012|
|Actual Primary Completion Date :||March 6, 2015|
|Actual Study Completion Date :||March 6, 2015|
Application of Microporous Polysaccharide Hemospheres (MPH)
Device: Microporous Polysaccharide Hemospheres (MPH)
Microporous Polysaccharide Hemospheres (MPH)
No Intervention: Control
- Total Drain Days [ Time Frame: 23 Days ]Time to Drain Removal
- Total Drain Output [ Time Frame: 23 Days ]Total Drain Output in mL
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647930
|United States, Georgia|
|Memorial Health University Medical Center|
|Savannah, Georgia, United States, 31404|